March 22, 2013

CME Programs to Reduce Opioid Abuse

Over the past several years, there has been significant attention drawn the prescription drug abuse and overuse of painkillers or opioids. Public health experts estimate that more than 35 million Americans age 12 and older have reported non-medical use of opioid analgesics during 2010 – up from 29 million in 200. In 2009, nearly 342,000 emergency department visits were associated with nonmedical use of opioid analgesics. In 2007, nearly 28,000 Americans died from unintended consequences of drug use, and of these, nearly 12,000 involved prescription drug pain relievers.

In response to these concerns, many states have proposed and adopted Prescription Drug Monitoring Programs. On the federal level, the Office of National Drug Control Policy (ONDCP) and the National Institute on Drug Abuse (NIDA) launched a new online learning tool, which will provide training for healthcare providers on proper prescribing and patient management practices for patients on opioid analgesics (painkillers). The new tools include continuing medical education (CME) modules.

In April of 2011, the White House unveiled a multi-agency plan aimed at reducing the “epidemic” of prescription drug abuse in the U.S.—including an FDA-backed education program that zeros-in on reducing the misuse and misprescribing of opioids. The action plan provides a national framework for reducing prescription drug diversion and abuse by supporting education for patients and healthcare providers, recommending more convenient and environmentally responsible disposal methods to remove unused medications from the home, supporting the expansion of state-based prescription drug monitoring programs, and reducing the prevalence of pill mills and doctor shopping through enforcement efforts.

Finally, the Food and Drug Administration (FDA) released its final Risk Evaluation and Mitigation Strategies (REMS) for extend-release (ER) and long-acting (LA) opioid medications this past summer. Continuing its efforts to combat prescription drug and opioid abuse, FDA issued a “Prescriber Alert” in early March, calling attention to prescribers to seek physicians “help in curtailing the U.S. opioid epidemic.”

In light of the expanding opioid epidemic in the U.S., FDA urged prescribers to take advantage of training on opioid prescribing, available as of March 1, 2013. This voluntary training will be provided at little to no cost through accredited continuing education (CE) activities supported by independent education grants. FDA will post all opportunities on its ER/LA Opioid Analgesics REMS site—currently there is only one activity through Boston University School of Medicine CME.

FDA emphasized the importance of the educational component of REMS. The first of these programs is available as of March 1 and more will become available. Although the programs will be funded by opioid product manufacturers, the content will be objective and independent.

Taking advantage of training opportunities on opioid therapy, now and in the future, is one of three key roles that FDA sees for prescribers in helping to curtail this pervasive problem. The other two are:

knowing the content of the most current drug labels for the opioids they prescribe, and

educating patients about the appropriate use of opioids, their potential risks, and proper disposal techniques.

FDA-approved drug labels are frequently updated based on additional science, new benefit-risk information, or public health implications regarding the medication. Labels of extended release and long-acting opioid drugs were changed in July, 2012.

Misuse and abuse of prescription opioids has reached epidemic proportions in America. While much of the problem is attributable to illicit use, appropriate use of medications for pain may also lead to unnecessary adverse events, addiction, and death for some patients. No group can be more effective in reducing this trendthan our nation’s front-line health care professionals, especially physicians and other prescribers. FDA sees three key roles for prescribers in curtailing the U.S. opioid epidemic.

ensuring that they have adequate training in opioid therapy,

knowing the content of the most current opioid drug labels (examples of the important information found in the labeling of two opioid drugs, OxyContin and Dolophine, are provided in the Key Label Examples tab), and

educating patients about the appropriate use of opioids, their potential risks, and proper disposal techniques.

The programs will be offered by independent providers of continuing medical education (CME) and based on an FDA blueprint that was developed with input from a wide range of stakeholders. Included will be information on weighing the risks and benefits of opioid therapy, the appropriate choice of therapy for each patient, and managing and monitoring patients and counseling them on the safe use of these drugs.

The program also will include learning to recognize potential for, and evidence of, opioid misuse, abuse, and addiction, as well as general and drug-specific information about ER/LA opioid analgesics. FDA encourages all opioid prescribers to take advantage of this valuable training to help ensure they have adequate and up-to-date training in opioid therapy.

The July 2012, REMS for ER/LA opioids also included significant changes to the FDA-approved drug labels for these products. The revisions focused on making the labeling consistent among ER/LA products, and on increasing the prominence of information available regarding risk and precautions, such as those for abuse and misuse, respiratory depression, and accidental exposure.

The drug label, or package insert, that accompanies all FDA-approved medications is the most complete source of information on the drug. Drug labels provide important safety and efficacy information and clinical data to prescribers on the benefits, risks, and appropriate use for all FDA-approved drugs. The FDA-approved drug label is one of the most useful tools prescribers have for providing safe and effective opioid therapy to their patients.

As with all FDA-approved drugs, each ER/LA opioid product label has information unique to its own chemical compound and formulation. However, ER/LA opioid labels also share many important similarities. Therefore, maintaining a thorough knowledge of the drug labels can help prescribers inform their decision-making to ensure safe, appropriate, and effective use. Examples of important information available in the FDA-approved labeling for two ER/LA opioids with particular impact on the epidemic --OxyContin (oxycodone hydrochloride controlled-release) and Dolophine (methadone hydrochloride) -- are provided in the Key Label Examples tab.

Labeling for all FDA-approved opioids can be found on the Drugs@FDA website, as well as at pharmacies and on many manufacturers’ websites. Labeling is also the root source of information prescribers receive from a wide variety of commercial online reference products and other resources educating prescribers about the safe and effective use of FDA-approved drugs.

Keep up with changes to drug labels: It is important to know that drug labels may change as new information on any FDA-approved products becomes available and that these changes occur frequently. We encourage prescribers to regularly review these changes. FDA’s MedWatch site provides easy access to safety labeling changes for FDA-approved drugs. This resource clearly identifies the parts of the label that have changed. The new alert also gives “Key Label Examples,” particularly about OxyContin and Dolophine.

FDA also emphasized the importance of patient education. FDA said that FDA-approved Medication Guides are key patient education tools. Pharmacies are required to provide them to every patient who receives an ER/LA opioid. Prescribers can also download all available Medication Guides for use in their offices. Among other valuable information, Medication Guides for ER/LA opioids inform the patient on safe disposal of their unused medication. FDA has also created a patient counseling document that prescribers can use to help educate patients on the safe and effective use of opioids.